Exhibiting at the SCDM 2018 Annual Conference

The Exhibition, held from September 23 – 25, 2018 is an integral part of the SCDM 2018 Annual Conference with the intention to provide a selection of top industry leaders, in one place, to the conference participants to learn more about industry trends and to provide excellent networking opportunities.

Comfortable exhibition facilities, conveniently located directly adjacent to the session rooms, are available for you at the Hyatt Regency Bellevue. Do not miss out!

If you have any question, feel free to contact our Sales Manager Deborah Sas at [email protected]

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The World’s Leading Advocate for the Discipline of Clinical Data Management.

Despite the best intent to leverage the newest technologies and comply with the recent regulation changes, most Data Management organizations have been processing data the same way for a long time. Fortunately for some and unfortunately for others, the accelerating pace of change is calling for action. The volume of data collected outside EDC is fast growing as our industry is crying for patient centricity which is leading to rapid adoption of eCOA, wearables, sensors and eSource solutions. The increasing cost of Drug Development and the need for better predictability of outcome requires use of more complex study designs such as adaptive and hybrid. Not to mention the need to embrace risk based approaches and advanced analytics. Unfortunately change will not stop there! Solutions based on Natural Language Processing, Artificial Intelligence and Machine Learning are maturing rapidly. So, is Data Management ready for all this?

The objective of this session is to provide a pragmatic and concrete view on how regulations and technology innovations will change the role and profile of Clinical Data Management within the next 5 years. We will also consider changes to related functions such as Clinical Programing and Medical Coding. We will share insights and roadmap from the SCDM Innovation committee.

If you are considering professional certification or would like to learn more about it, please join us for the Becoming a Certified Clinical Data Manager (CCDM) session! This session will cover the current exam content and resources. The session will focus on preparing for the Exam including hearing from a panel of recently minted CCDMs!

Panel DiscussionTRAINING THE PAST, PRESENT AND NEXT GENERATION OF CLINICAL DATA MANAGERS

How does one stay up-to-date in the ever-changing role of a Data Manager (DM)?

Training paradigms, opportunities, and resources are more limited each year. As research budgets continue to become leaner and leaner, often DM educational and professional development dollars become scarcer.

Gone are the days of a DM who possesses the entire skill set necessary to conduct all DM activities from start-up to data base lock. Companies now focus on performing or outsourcing specific DM tasks, and the ability for a DM to see the “big picture” is waning.

In this session, we will explore the opportunities for a proactive DM (of any generation) to ensure that they have achieved the SCDM core competencies, whether sponsored by their employer or pursuing on their own. We will review the training tools and resources that have been traditionally used in Industry and how these are being adapted for a wider research environment using today’s technologies.

Session 16 - Does The Quality of Your Clinical Data Keep You Up at Night?

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Evergreen Ballroom, Lobby Level

Category: Niche

Panel Discussion

DOES THE QUALITY OF YOUR CLINICAL DATA KEEP YOU UP AT NIGHT?

In this session, Oracle Health Sciences’ Julie Smiley moderates a panel of industry experts, from Pfizer, Novella Clinical, Covance, Cytel and Premier Research, to explore their greatest challenges when it comes to clinical data management. Some of these challenges include the introduction of AI and machine learning, the influx of new data sources, and migration to the cloud. This session will offer insight into how these organizations are solving these challenges, and will shed light on what people, processes and technologies are needed in order to successfully manage clinical data.

In a long-standing tradition, SCDM is pleased to announce the 2018 SCDM Annual Conference Leadership Forum, will take place on 23 September 2018 at the Hyatt Regency Bellevue, in majestic Seattle, Washington.

With the theme of Leading DM into the Future: Tackling Challenges of Today – Creating a Compelling Vision for Tomorrow, we will go on an exciting and highly interactive journey in three parts covering the challenges clinical data management’s leaders face today, the rapidly evolving technologies to address these challenges re-imagining the discipline of clinical data management in the future. We will explore the existing disruptive technologies that are driving this evolution, and the future of Clinical Data Management, posing the question: what does our future look like?

The day starts with an engaging roundtable discussion related to your top challenges in data management and progresses from present to future. Enhancing our three-part program will be interactive roundtable and panel discussions around the current and upcoming regulations and their impact on our work, as well as updates from the SCDM Innovation Committee.

As leaders in the industry, we invite attendees to take this opportunity connect and exchange views on challenges, regulations, innovations and trends that are currently shaping the data management world.

Session 12 - Get Off My Cloud: How IT Infrastructure Affects Privacy and Perfoermance in Eclinical Systems

Tuesday, September 25 | 08:00 AM – 09:00 AM

Location: Regency Ballroom E-G, Second Floor

Category: Tech

Panel DiscussionGET OFF MY CLOUD: HOW IT INFRASTRUCTURE AFFECTS PRIVACY AND PERFORMANCE IN ECLINICAL SYSTEMS

While Electronic Data Capture (EDC) and Clinical Trial Management Systems (CMTS) streamlined the execution of clinical trials, the ultimate goal of entirely paperless trials is still to be achieved. With a variety of new software applications emerging almost every day, data managers must be educated on these systems, EDC in particular, to fully compare and contrast their options and determine which products will be optimal for their studies. It is critical that researchers ask the important question: how and where is this software application hosted? High cost, among other factors, has incited the movement away from on-premises hosting towards “the cloud.” Even when a researcher opts for a cloud-based clinical software, several hosting variations within “the cloud” exist. These important cloud-based hosting variations can affect both privacy and performance during the life of the study, thus affecting sponsors, as well as CROs and sites. This presentation will discuss the pros and cons that surround on-premises, public cloud, and private cloud options. Depending on a study’s needs, where and how an EDC software is hosted can have long-term and short-term implications on cost, efficiency, and compliance. It is important to be aware of the differences between these hosting options and ask the right questions when speaking to vendors. This presentation will serve as a primer to guide Data Managers through the various options and better equip them to ask the right questions.

As the flood of new clinical trial data sources rapidly grows, so do the challenges around clinical data quality, traceability and oversight.

In this session, Oracle Health Sciences’ Senior Director of Product Strategy, Greg Jones, dives into a recent study that reveals insight into these current clinical data management challenges, and presents three practical ways the industry can combat these challenges in order to bring new and innovative therapies to market faster, and at lower cost.

The cloud has been a transformative technology for every aspect of our personal and professional lives. But while clinical trials have not adopted cloud technology as rapidly as other industries, the benefits are getting harder and harder to ignore. Decentralized workforces, trials that span the globe, and an increasing number of stakeholders are making trials more complex to manage. We will show, complete with demos, how an integrated, cloud-based data collection platform can reduce timelines, improve patient retention, simplify management, and much more.

Session 30 - Clinical Trials of The Future - Where are We Headed?

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Evergreen Ballroom, Lobby Level

Topic: Tech

Round TableClinical Trials of the Future – Where are we headed?

This session will allow the perspectives of a wide-variety of seasoned industry personnel to share their perspective on where Clinical Trials are headed in the future and what attendees of the SCDM conference should be doing to prepare themselves for the future. An initial discussion among the panelists and the facilitator will explore topics ranging from digital health, virtual trials, artificial intelligence and connected sensors/devices, etc. Following the discussion, questions will be taken from the audience for the panelists to be able to weigh in from their perspective.

The session is a play on FREAKONOMICS, and in particular the TELL ME SOMETHING I DO NOT KNOW series.

Each presenter will be invited, in turn, to persuade the audience, and a panel, that their chosen fact or idea will transform our industry more than any other in the next 5 years. Each presenter has been selected because of their deep domain knowledge, but also for their ability to be imaginative, concise, precise and above all convincing and compelling.

Each presenter will have just 12 minutes to persuade, to convince and to make their case. After 12 minutes (strictly adhered to), there will be a 5 minutes opportunity for the panel to ask questions.
There are only 2 rules:
•Each presenter must stick to their own topic, and cannot look outside of your topic
•There are no other rules

We will repeat until each of the 4 presenters has completed their turn. After each presenter has delivered their pitch, we will turn to the audience and the panel (independently) to vote. The panel will be formed from some executives in our industry and will be neutral to all. I do not get to vote! In other words, this is all about pitching the 4 presenters against each other (in fun) and then letting the audience pick a winner.

There will be a prize for the panel winner, and the audience winner. It will be interesting to see if we have one winner take all!

Session Chair:Richard Young, VP, Vault EDC, Veeva Systems

Speakers:

The New InvestigatorMike Ryan, TrialSpark

The New PatientBruce Hellman, BSc, MBA, CEO , uMotif

The New Decision MakerKarim Damji, Saama

The New TechnologyMaryAnne Rizk, PhD, President of Rizk Management LLC

Learning Objectives:

The New Investigator

How are the roles of the Investigator changing?

How does this impact our approach to clinical trials?

The New Patient

What does the new Patient look like?

What is their expectation for participating in trials, and how does this impact our approach to clinical trials?

As technology advances and standards are mandated, industry has been able to build applications that change the way we build databases, manage standards, review, clean and manage clinical trial data. This session will explore how industry representatives from multiple disciplines consume these standards and use these technologies in their jobs. Now is your chance to ask the questions that management asks you:

How can we accelerate timelines?

How can we increase quality?

This panel discussion will address:

Metadata registry – what is it and how does it help me?

Benefits of applying standards end to end in a clinical trial

Clinical Data warehouse with analytics – opening your eyes and seeing data the way it was meant to be

All 3 applications are based on CDISC standards. Each speaker will provide “real world” examples how the application impacts timelines and improves efficiencies.

Session 8 - Leveraging High Impact Information: Lessons and Best Practices in a Data Driven Culture

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

Presentation

LEVERAGING HIGH IMPACT INFORMATION: LESSONS AND BEST PRACTICES IN A DATA DRIVEN CULTURE

Every company aim is to make sense of its data to help predict trends and make informed decisions. Even after the procurement of new technologies, companies struggle to find meaningful evidence that tell a story. In this session, we explore effective measurement of clinical data management and unique ways to make your data flashy again.

Focus and emphasis of quality control throughout data management processes. Diverse presentations across key areas of concern for data management including but not limited to data integrity, defining quality and best practices. At the conclusion of each presentation interaction will be encouraged through a question and answer session as well as open discussion. The forum to present information and have active conversation around methodology and best practices. Possibility of exercises upon conclusion of presentations to promote communication and ensure the understanding of what has been presented.

As clinical trials become increasingly complex involving data obtained from varying sources, tapping into the extensive array of new technologies and visualizations can enable teams to maximize their efforts and strengthen the integrity of the data. This session will highlight practical strategies that data management teams can implement while working with vendors and differing data sources. Speakers will present some key examples in which we can justify that applied technology leads to increased efficiency resulting in quality data.

• By learning how to use data visualizations and dashboards, attendees will be able to track performance over time and identify outliers in data to increase accuracy of data
• Given examples of how being proactive in identifying barriers in productivity, attendees will be better poised to take corrective actions to address performance issues
• Through examples showing creative applications for common technologies, attendees will be able to apply new vision to creating workflow improvements
• After seeing how small changes can make big differences in workflow, attendees will be able to identify improvements leading to increased efficiency

EVERYTHING I KNOW I LEARNED IN DATA MANAGEMENTLeaders from a variety of businesses, who all began in Data Management, will share what they learned in CDM and how they have applied it in their careers and in their current roles. Attendees will gain an appreciation of how they can use the knowledge and expertise from a CDM background in a broader career pathway.

Roundtable“DON’T YOU (FORGET ABOUT ME),” THE BREAKFAST CLUB…OF DATA MANAGEMENT!

Interactive session featuring people from different backgrounds, experiences and expertise. Each will bring their own perspective of Data Management, and will allow, along with audience participation, a lively discussion on how we can work together to make our roles better. Sometimes the best ideas, or advice, come from the person you least expect.

Session 32 - Time to Mutate: How Emerging Technologies Will Shape the Future Role of Data Management

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

PresentationTIME TO MUTATE: HOW EMERGING TECHNOLOGIES WILL SHAPE THE FUTURE ROLE OF DATA MANAGEMENTWith aspects of clinical research seeing rapid expansion into more automated and advanced approaches to day-to-day work tasks, clinical data management is nearing a required adoption of more sophisticated methods of mining study metadata, identifying and cleaning anomalous data, and working with a wider variety of available data sources beyond the traditional electronic data capture (EDC) system model, including EMR/EHR systems. As clinical trials continue to move toward the use of ePRO, wearable technology, and biosensors for data collection, data volume and data velocity will likely render non-algorithm based approaches to data cleaning and error identification obsolete. Deep learning, predictive analytic and machine learning algorithms will become commonplace tools available to clinical data management to expedite and, in some cases, eliminate tasks that have traditionally been handled manually. In addition to the standard arena of clinical data, there are a number of non-traditional areas in which clinical data management is likely to expand. That being said, there is a salient concern that Data Management as it exists today will not have a place in the clinical research enterprise in a future potentially dominated by AI applications. In order to keep up with current trends and remain relevant, those in clinical data management positions must be ready to adapt to the rapidly-changing landscape. This session will be description of the gap between the current state of our industry and where we are likely to find ourselves in the near future based on the evolution of data systems and technology. In addition, we will attempt to paint a clear and actionable path to improving our skill set for those in Data Management today.

Session 31 - Being Digital Clinical Data Manager, What IT Means For The Industry! - A Visionary Approach To Revolutionize CDM Practices

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Panel DiscussionBEING DIGITAL CLINICAL DATA MANAGER, WHAT IT MEANS FOR THE INDUSTRY! – A VISIONARY APPROACH TO REVOLUTIONIZE CDM PRACTICES

The Clinical Research Industry is currently at a Juncture where disruptions are happening in Clinical Data Management process and the role of Clinical Data Manager seems to evolve as a Digital Data Manager. Here is the reason:

ATOM (Analytics – Big Data, Risk Based Monitoring)

Technology – Automation of many processes

Tool and accelerators to reduce manual work

BOTs to do repetitive task

Overflow – Social Media

Mobile and IOT is creating an overflow of the data to manage, retain, analyze to make sense of it, Mediation

e-Source and connected devices requires mediation of the new way of doing clinical research which is not fully executed and explored.

So, from just managing clinical data, it will evolve to lead many digital initiatives and would be called as Digital Data Manager.

The role of data management professionals in the science of clinical trials continues to be central to the integrity of the data relied upon as evidence for important health decisions. The environment for the clinical research enterprise is rapidly changing. Significant milestones in the development of data management as a profession, changes that impact the data integrity including a discussion of the origins of the SCDM, the origins and purpose of the GCDMP and other standards will be provided. The importance and future role of SCDM to advance the profession of data management, changes in data management and information science, and experience needed in the development of this profession will be discussed.

Closing & Award Ceremony

Session 24 - The Inspection Experience Through The Eyes of a Data Manager

Tuesday, September 25 | 03:30 PM – 05:00 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

PresentationTHE INSPECTION EXPERIENCE THROUGH THE EYES OF A DATA MANAGERBeing involved directly in an agency inspection is a very unique experience and although these can be high intensity situations and a little stressful, the opportunity for learning by being involved in them is invaluable. Since not every data manager will directly be involved in an inspection over the life of the career, it is still imperative that all DMs have a good idea of how they work and how DM is involved and impacted. It will be very valuable to all data managers to really get a good feel for what is expected, from DM, related to an inspection using real life experiences. Understanding how an inspection happens and examples of questions asked and scenarios experienced can give any data manager a much better idea about how their work directly relates to the potential discussions during an inspection. During this session, data managers across the clinical data management industry will share their experiences and involvement in inspections.

Attendees will be able to understand how information learned through health authority inspections can be translated into process improvements to limit and/or prevent data management related findings and observations later

Attendees will be able to define the key steps they can start to take in their business to support data managers interacting with health authorities

SMART is an architecture whereby cloud-based third-party applications may be launched from within an EHR system. FHIR provides a compact and efficient mechanism for securely retrieving appropriate data from the Electronic Health Record. The combination finally provides the “holy grail” of clinical data collection, namely the ability to programmatically extract relevant clinical trial data from the Electronic Health Record, without needing to install anything at the investigative site. This session will describe the technologies, processes and recommended workflow to achieve this dream.

With technology capabilities growing exponentially, and the ever-increasing complexity of clinical research, the pace of innovation relevant to clinical data management is changing rapidly. eSource, mHealth, RBM, IRT, CTMS, Data Warehouse systems and more are capturing some or most of the data that would traditionally be captured by EDC systems. The challenge, however, is that these disparate systems and processes are creating multiple versions of truth for the same data – adding to, instead of reducing, trial complexity. Current attempts to solve this challenge through the integration of clinical research systems is falling far short of the goal, and can in fact create greater inefficiency, adding time and effort to the overall management of data and potentially impacting data quality.
This panel discussion will explore the hard questions life sciences companies face are addressing these challenges in today’s CDM world, and what they are doing about them, including:

Is a “single source of truth” for clinical data the way forward? Is it really possible?

What are the current challenges with integrations between clinical research products and systems?

What are the best practices to make the integrations work better?

What can we learn from other regulated industries such as finance and its application of new technologies such as blockchain to solve data challenges in life sciences?

How will greater connectivity of clinical data make data managers and data scientists more productive?

How can we leverage the Internet of Things to have better connected and integrated clinical research systems – while maintaining informed consent and data privacy?

PresentationUTILIZING GCDMP AS A TRAINING TOOL FOR CLINICAL DATA MANAGERS

Data Management has become more complex in the past couple of decades. To address this complexity, organizations need to train their Data Management staff on the best practices to assure the quality of the data at the end.

In this session, presenters from four different countries (Unites States, Japan, China, and India) will share their journey in using GCDMP to train their Data Management staff on best practices in their organizations. The presentations will encourage other organizations to utilize GCDMP in an effective manner to increase quality of their processes and data.

Academic research institutions support multi-center and site based research through significant institutional infrastructure, resources and technologies for collecting and managing data for clinical studies, and enabling data from EHR warehouses to support studies integrated within the healthcare environment. Industry sponsored projects leverage these capabilities while also fulfilling their distinct scientific, regulatory and business needs. Data and data management practices at the intersection of these stakeholders present unique opportunities to collaborate and advance research practice while recognizing the different needs and requirements represented by those different perspectives. Come learn about the trends and key challenges facing the SCDM membership from principal investigators (PIs), administrators, and others who hold leadership roles in academia.

Session Chair:Emily Patridge, University of Washington

Speakers:

Meredith Zozus, University of Arkansas for Medical Sciences

Jason Morrison, Director of Research Information Technologies, University of Washington

Session 14 - More Than Checking Boxes: Integrating Electronic Informed Consent in a Compliant and Ethical Way

Tuesday, September 25 | 11:15 AM – 12:15 PM

Location: Regency Ballroom E-G, Second Floor

Category: eConsent

Panel Discussion

MORE THAN CHECKING BOXES: INTEGRATING ELECTRONIC INFORMED CONSENT IN A COMPLIANT AND ETHICAL WAY

Regulatory authorities have been clear that Informed Consent is a multifaceted process that goes far beyond obtaining a signature. Genuine consent involves providing potential participants with adequate information about the research to allow for an informed decision to participate, facilitating and verifying comprehension of the information, and allowing adequate opportunity for questions and consideration. The process often continues after enrollment. Investigators are frequently obligated to provide additional information to participants as the research progresses, and even obtained informed re-consent.

Electronic informed consent (e-Consent) must accommodate all these requirements. Done well, e-Consent can maximize patient understanding, engage non-English speakers with multilingual tools, improve documentation and reporting, and standardize the consent process across sites, all while reducing cost and administrative burden. Attendees of this session will learn how to determine the suitability of e-Consent in light of a study’s setting, participant profile, and indication (among other attributes), as well as the best way to adapt the principles of fully informed consent in its usual, paper-based context to one where the process is electronic.

The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA on current key topics concerning Clinical Development and the Data Management discipline. In addition to specific updates the panelists will provide, participants will be offered to the opportunity to ask their questions during the Q&A portion of the session. Do not miss the chance to determine what is critical to our regulators, to your peers, to you and your organization.

PresentationGCDMP REVISION HIGHLIGHTSYou’ve heard that chapters were under revision. You’ve seen notices for the draft chapter webinars. Now they’re here! This session will present revisions to key GCDMP Chapters including Data Management Plan, CRF Completion Guidelines, Vendor Selection and Management and the EDC Chapters. Come hear what’s new, how to comment on the draft chapters and how to participate in this major GCDMP revision.

Session Chair:Meredith Zozus, University of Arkansas for Medical Sciences

Speakers:

Carolyn Famatiga

Dawn M. Edgerton, MBA, RAC , Owner, Edgerton Data Consulting, LLC

Maxine Pestronk,MS, RD, LDN, CCDM, Founder, P4CDM

Session 10 - Virtual Trials and The Data Manager

Monday, September 24 | 04:00 PM – 05:30 PM

Location: Regency Ballroom A-D, Second Floor

Category: Career Development & Leadership

Panel Discussion

VIRTUAL TRIALS AND THE DATA MANAGER

This session aims to look at the concept of virtual trials and patient centric research through the eyes of a data manager. We’ll look at how using eSource and patient dashboards will challenge the traditional role and tools of a data manager.

This session will be unique in its presentation format. The six selected speakers who will entice you with a brief look into their world and a recent accomplishment. Each presenter will share a key example of something they have created and delivered within their organization that shows creativity and overcoming everyday challenges in Data Management. The presentations will each be approximately 10 minutes with time at the end of the session for Q&A. These speakers will Spark your Interest and Ignite your Future!

Attendees will have the opportunity to vote through the mobile app the most interesting and creative presentation in this session. The People’s Choice Award will entitle its winner to a two minutes podcast to promote their accomplishment, on the SCDM website and social media channels.

Session 4 - Data Management in The World of 'Direct to Patient' or 'Virtual Trials'

Monday, September 24 | 01:45 PM – 03:15 PM

Location: Evergreen Ballroom, Lobby Level

Category: Tech

Panel Discussion

DATA MANAGEMENT IN THE WORLD OF ‘DIRECT TO PATIENT’ OR ‘VIRTUAL TRIALS’

Data Management in the world of ‘Direct to Patient’ or ‘Virtual Trials’ Clinical Research has come a long way since using paper in the 1990s. Most studies have adopted electronic solutions with rapid improvements in connectivity and wide availability of clinical technology solutions. Continued enhancements in technology and expansion of clinical research industry in emerging countries and in established geographies are triggering newer models for clinical trials.

Direct to patient or virtual studies allow inclusion of patients without proximity to a specific site or location. This patient centric approach puts patients rather than the trial site at the center of the process. The design of the study as well as the conduct of these studies ensure their patient centricity. Instead of a patient going to a site for the clinical trial, the clinical trial comes to the patient’s home. Patient recruitment, enrolment, engagement and retention, data collection including its management and follow ups are all usually managed from a central office and are supported by staff at regional or local hubs. This new model creates opportunities for new way of collecting and managing trial and operational data. Very limited or zero onsite monitoring creates new challenges in cleaning the clinical trial data.

Attendees will appreciate the evolution of clinical trial processes due to developments in technology solutions for clinical research from Protocol design all the way to Submissions

Attendees will get a preview of a new model of conducting clinical trials namely: Virtual Clinical Trials or Direct to Patient Clinical Trials. The will also understand the technology framework required and its impact on data management

Attendees will be able to describe advances in clinical trial technology solutions that enable virtual clinical trials and utilize such solutions and approach to clinical trials in their organizations. We will also focus on Data Management in such trials and attendees will understand any changes in approach needed to plan and execute DM services for such trials

For decades, integration between EHR and EDC systems has been seen as the “holy grail” to optimize clinical research. Finally, key technologies and standards are now making such integration a reality. The presenter will explain how SMART and FHIR on the EHR side and CDISC CDASH and ODM on the EDC side allow for integration — without protocol-specific custom coding. The speaker will describe the solution developed by Clinical Pipe and implemented successfully in oncology clinical trials across multiple academic clinical trial centers. Clinical Pipe can integrate with any SMART on FHIR EHR system and connect to any EDC system with a real time API. As of July 2018, the application integrates the 4 leading EHR systems and export data in real time to Medidata Rave and Protocol First EDC. The speaker will also address downstream operational impacts of acquiring data “automatically” from the EHR.

Medidata – Product Showcase Room 2

Beyond eConsent: How a Unified Platform can simplify and streamline Clinical Development with a Patient Centric Approach

Abstract: Adopting an eConsent solution comes with many benefits by itself, less burden on patients and sites, improved learning and retention of trial information and better overall patient retention. But more benefits are unlocked when eConsent is used in conjunction with a platform that allows patient data to seamlessly flow into RTSM and EDC capabilities.

Join us for this live demonstration to learn how Medidata platform streamlines the patient experience while reducing study timelines by allowing patients to enroll electronically, automatically triggering randomization and kit procurement, so patients can fully participate in the trial from in their initial visit.

Product Showcases - Veeva & IBM

Tuesday, September 25 | 10:30 AM – 11:15 AM

Veeva – Product Showcase Room 1

Built on a modern unified clinical platform, Veeva Vault EDC allows you to run the trial you want, not the trial your technology limits you to. Quickly deploy studies in weeks, not months, and make in-flight amendments without migrations or downtime. The ability to integrate and maintain complete and concurrent trial data, including non-CRF data, provides real-time insights and dramatically improves productivity.

IBM Clinical Development – Product Showcase Room 2

IBM Clinical Development is a unified solution positioned to Transform the Clinical Trial industry by leveraging cognitive capabilities, data assets, IoT and EMR/EDC integrations. Designed to optimize protocol development, enhance patient/site recruitment and digitize clinical trial processes; IBM Clinical Development can help reduce the time and cost of clinical trials and help life science organizations bring therapies to market faster to benefit patients.

These applications are powered by our Innovation Centre of Excellence, which has continuously delivered tools and frameworks that drive measurable operational improvements. Some of the key initiatives taken up by this CoE are related to EDC Accelerators, Test Data Simulation, and Statistical Programming Workflow as well as advancements in Reporting & Analytics.

OmniComm – Product Showcase Room 2

Clinical Data at Your Fingertips: Using Modern Browser Techniques to Streamline Data Management

Browser technology has evolved since the early days of developing web based EDC, for example the introduction of HTML5. Standards have also been developed and adopted to provide a more consistent and intuitive user experience across web sites. Our demo will show how we have incorporated these into a modern UI for Data Management.

FROM DATA MANAGEMENT TO DATA SCIENCE: RAISING THE BAR FOR SCIENTIFIC ABSTRACTS AND PRESENTATIONS

As the field of clinical data management transitions from one of operations to a bona fide scientific subspecialty, the profession’s scientific base will also need to evolve. The purpose of this session will be to share ideas and provide recommendations for strengthening the scientific rigor of abstracts submitted for possible presentation at the SCDM annual conference. This ‘how to’ session will include examples and recommendations for practice, including principles that will increase an abstract’s chances for acceptance and be generalizable to other data science conferences, as well.

Session 32 - From Spreadsheets To Artifial Intelligence: How Do We Get From Here To There?

Wednesday, September 26 | 10:30 AM – 12:00 PM

Location: Cedar Ballroom, Second Floor

Category: Tech

PresentationFROM SPREADSHEETS TO ARTIFICIAL INTELLIGENCE: HOW DO WE GET FROM HERE TO THERE?With aspects of clinical research seeing rapid expansion into more automated and advanced approaches to day-to-day work tasks, clinical data management is nearing a required adoption of more sophisticated methods of mining study metadata, identifying and cleaning anomalous data, and working with a wider variety of available data sources beyond the traditional electronic data capture (EDC) system model, including EMR/EHR systems. As clinical trials continue to move toward the use of ePRO, wearable technology, and biosensors for data collection, data volume and data velocity will likely render non-algorithm based approaches to data cleaning and error identification obsolete. Deep learning, predictive analytic and machine learning algorithms will become commonplace tools available to clinical data management to expedite and, in some cases, eliminate tasks that have traditionally been handled manually. In addition to the standard arena of clinical data, there are a number of non-traditional areas in which clinical data management is likely to expand. That being said, there is a salient concern that Data Management as it exists today will not have a place in the clinical research enterprise in a future potentially dominated by AI applications. In order to keep up with current trends and remain relevant, those in clinical data management positions must be ready to adapt to the rapidly-changing landscape. This session will be description of the gap between the current state of our industry and where we are likely to find ourselves in the near future based on the evolution of data systems and technology. In addition, we will attempt to paint a clear and actionable path to improving our skill set for those in Data Management today.

With an exponential growth of data in recent times & rapid advancements happening on technology front, the need of hour is to generate insights from this massive amount of data. These emerging technologies help to improve the quality of data that we collect and enable us to take informed decisions. Artificial Intelligence (AI) is the ability of a computer or machine to simulate human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages, while Machine learning (ML) may be simply defined as a compilation of algorithmic techniques that can be used to identify patterns to enable or automate decision-making activity. As an example, Natural Language Processing (NLP) can be used to ‘read’ free text in CRFs & assist in scientific review of data. Large data sets from past clinical programs can ‘train’ the ML algorithm and can then be used for subsequent data review, cleaning and analysis. NLP can also help with describing relationships between medically coded terms. Some of the following themes that could be put into practice:

Pre-programmed therapeutic area based data checks in Clinical Data Repository for additional data review at a Program Level

Deploy machines to learn from ongoing studies. Utilize this machine learning to enhance the data checks on an ongoing basis, that in turn improves data review across studies in a Program

Enhance auto-coding using compiled data from multiple studies to enhance the percentage of auto-coded terms

ML based site performance information on query response times and suggestions for action during clinical monitoring. We intend to focus on practical applications and case studies of these emerging technologies in clinical research space during this session

Central monitoring is one of the key pillars of implementing ICH-E6(R2) compliance. Currently, central monitoring approaches at organizations varies from simple and manual review of site level key risk indicators and performance indicators to holistic clinical review of subjects sites and utilizing data-driven automated technology for site risk scoring. The approach utilized for central monitoring is dependent on various factors like availability of skilled resources, appetite for relying heavily on data driven processes, type of technology utilized and maturity of operations.

This session will discuss process framework and technologies utilized for central monitoring in different type and size of organizations. It will focus on:

Explaining different approaches utilized for identifying and measuring risks

The landscape for data managers have changed drastically from the past. From earlier days when a data manager would be doing data entry, make a database and send queries to site, the data manager now has many stakeholders like statisticians, medical writers, preclinical scientists, study responsible physician, medical monitors to name some. There is an expectation from data managers to borne skills which can bridge gap between technical and scientific information and deliver a complete package.

It is increasingly becoming important for data manager understand the impact of data he / she is handling on the overall analysis. This expectation requires a person to understand not only data management as well as SDTM; but also, an understanding of how the drug functions and why a particular parameter can become very important for overall efficacy of the drug. Very often there are expectations that a data manager should have experience in a particular therapeutic area.

While technical skills and soft skills of data managers are being discussed, very little is being talked about the therapeutic area knowledge requirements of a data manager in terms of; what exactly is required, an understanding of assessments in a particular TA or also theoretical knowledge? Is this a necessity and what are the value adds? And most importantly, how to develop TA knowledge of data managers? This session aims to look at the concept of virtual trials and patient centric research through the eyes of a data manager. We’ll look at how using eSource and patient dashboards will challenge the traditional role and tools of a data manager.

The Bill & Melinda Gates Foundation supports partner organizations that conduct high quality clinical and epidemiological trials in challenging locations throughout the world, oftentimes under challenging situations. Regardless, the need for collecting quality data even in the most trying situations is no different than for any other trial. In this keynote, Mr. Kern will highlight some of the approaches the Bill & Melinda Gates Foundation have advanced with their partners to do this important work that impacts the lives of so many in the world.

Registration Booking Period

For bookings made and paid before June 13: a discounted ‘Early Bird’ registration fee applies.

After June 13: the increased ‘standard’ registration fee is applicable to all bookings until September 22.

After September 22: the onsite registration fee will be applicable.

Please note: from September 22, online registration will be closed. As of this date, onsite fees apply and delegates will have to register onsite at the registration desk.

The Bill & Melinda Gates Foundation supports partner organizations that conduct high quality clinical and epidemiological trials in challenging locations throughout the world, often times under challenging situations. Regardless, the need for collecting quality data even in the most trying situations is no different than for any other trial. In this keynote, Mr Kern will highlight some of the approaches the Bill & Melinda Gates Foundation have advanced with their partners to do this important work that impacts the lives of so many in the world.

Steven E. Kern, PhD is Deputy Director of Quantitative Sciences at the Bill and Melinda Gates Foundation. Visit the Keynote Speaker page for more details.

LOCKABLE CHARGING STATIONS

Unique opportunity

$7,550

A breakthrough strategy that connects with AC participants. Provide an invaluable customer service with this exclusive branding opportunity. The charging station sponsorship provides participants an easy way to charge their handheld devices, tablets and laptops at no cost. These kiosks are customizable depending on the branding initiatives. Highly visible with locations in key areas of the AC venue.

FULL SERVICED MOBILE COFFEE CART

Unique opportunity

$7,550

The opportunity to sponsor a mobile coffee cart catering point within the AC venue, brand the space with your logo and literature. There is room for creativity with this opportunity in the most bustling area of the Show.

CONFERENCE LANYARDS

Unique opportunity

$6,650

Benefit from prime visibility by placing your company logo on the conference lanyards provided to every participant registered to the conference. The lanyards will be customized with the sponsor’s logo as well as the SCDM 2018 Annual Conference logo. The production cost of the lanyards including 1 x one color.

Fun Facts About Seattle

The land that is now the city of Seattle has been inhabited for at least 4,000 years. George Vancouver was the first European Settler to visit Seattle in May 1792 during his 4-year-long expedition to chart the Pacific Northwest.

Seattle is the birthplace of Starbucks, the world’s largest coffee chain. You can buy a unique mug (if you collect them) at the original Starbucks in Pike Place Market, first opened in 1971.

Seattle is home to the world’s first gas station, opened on East Marginal Way in 1907.

Seattle is ranked the most literate city in the country, withthe highest percentage of residents with a college degree or higher.

EXHIBITOR ADD-ONS

UPGRADED WEB LISTING – $275

Benefit from additional visibility by adding your company logo and link to your website on the SCDM 2018 Annual Conference website.

UPGRADED LISTING IN MOBILE APP – $225

Take advantage of upgrading your company listing in the AC mobile app, available to all registered conference participants and overall CDM community, by adding your company logo.

PROMOTIONAL GIVE-AWAY CONTEST – $50

Take advantage of entering the first ever ‘Promotional give-away contest’ at the SCDM exhibition. The right trade show giveaways can help generate leads and support integrated marketing messages that will prompt participants to tie that message back to your company long after the AC has ended. To enter the contest please do submit a picture of your give-away by email to [email protected] latest by September 3, 2018.

Payment Information

All costs referred to are in USD and all payments must be made in USD. During the online registration process, payments by major credit cards (American Express, VISA and MasterCard) are accepted.

Payment must be received prior to the conference. Delegates with outstanding payments will be asked for payment onsite or a proof of payment is requested. If one of these cannot be provided, the delegate may be refused permission to attend the conference.

Please note that SCDM does not accept conference registration fee payments by check.

IMPORTANT NOTE:
Please do state your name and invoice reference when proceeding your payment by bank transfer.

Group Registration

A group registration is available for a group of 10 or more paying delegates from the same company registering for the full event (member and/ or non-member) and acceptance is at the discretion of the organizers.

The group registration cannot be combined with other discounts (speaker or session chair discount for example).

Group discounts are only available with the special group registration form which needs to be send duly completed by email to [email protected].

Group registration (10+ registrations made in one transaction only) entitles you to a 10% discount (no other discount combination is allowed).

To qualify for this discount, all delegate names and details must be provided at the time of booking.

Attendees that have already registered are not permitted to cancel and rebook under a group discount.

Cancellation Policy

In the event of cancellation, written notification must be sent by email to [email protected].

The following cancellation fees will apply:

Cancellations received up to May 30: Full refund minus a $100 administration fee

Cancellations received as of May 31 or no-shows: No refund

Product Showcase

Limited opportunities

$1,850

Interested in showcasing your product? Sign up for your 45-minute session in our 20×20 demo booths located in the exhibit hall and invite your prospects!
Complete with audio and seating.

Guest Room Amenity & Room Drop

Limited to 3 sponsors, one night each

$2,000

Reach out to the conference participants on peak nights with personal favors highlighting your company. Limited to 400 rooms. Items to be provided by the sponsor (subject to approval by SCDM).

Notepads & Pens

Limited to 1 sponsor

$4,500

Take advantage of placing your company logo on notepads and pens distributed to all full conference participants. The production cost of the notepads & pens including 1 x full colour logo imprint is included in the package value.

Reusable Water Bottle

Limited to 1 sponsor

$6,500

Increase you companies’ visibility by customizing reusable water bottles with your company logo. The production cost reusable water bottle including 1 x one colour logo imprint is included in the package value.

KNOWLEDGE SPONSOR

Exclusive

Value: $27,000

Including all items:

-Status as the Knowledge Partner

-45-minute Product Demonstration (September 24 or September 25 – date and timing to be confirmed by SCDM)